Omalizumab for atopic dermatitis: case series and a systematic review of the literature

Abstract

Omalizumab is a recombinant humanized monoclonal antibody targeting the high-affinity Fc receptor of IgE, registered for the treatment of chronic spontaneous urticaria and severe allergic asthma. We present a case series of nine patients with atopic dermatitis (AD) treated off-label with omalizumab and a systematic review of the existing literature. Patients were selected consecutively from a tertiary dermatological referral center during a 5-year period. All patients were treated with omalizumab at a starting dose of 300 mg subcutaneously every 4 weeks. Systematic literature searches were performed in PubMed, Web of Science, EMBASE, and ClinicalTrials.gov to identify any study (case reports, case series, and controlled trials) evaluating the effect of treatment with omalizumab in AD. Based on physicians' assessment, 50% of our patients had a good or excellent response to treatment with omalizumab; a further 12.5% had a moderate response, while 37.5% experienced no response or deterioration of symptoms during treatment. Treatment was generally well tolerated. Twenty-six studies with a median of four patients each (range 1-21), comprising 174 patients, were included in the systematic review. Summed over all studies, a total of 129 patients (74.1%) experienced a beneficial effect of treatment ranging from little to complete response. Omalizumab appears to be a safe and well tolerated, however expensive, treatment with some clinical benefit in patients with severe recalcitrant AD. Recommendation for use in clinical practice awaits evidence from larger randomized controlled trials.

Systemic Treatment of Adult Atopic Dermatitis: A Review

“…However, Belloni et al reported that low-dose omalizumab therapy (10 cycles of 150 mg subcutaneously at 2-week intervals) was able to decrease SCORAD levels by more than 50% in only 2/11 (18.2%) subjects and by 25–50% in 4/11 (36.4%) AD patients [117]. Similar results have been recently reported by Holm et al, who observed good or some effects in disease improvement (through SCORAD scores) in only 4/9 (44.5%) adult AD patients treated with omalizumab [118]. Conversely, more significant results in limiting AD skin symptoms have been reported in patients with concomitant AD and bronchial asthma by small case series involving almost 40 subjects [120–124].…”

“…Moreover, Krathen and Shu described their experience with three adult patients with severe AD treated with omalizumab (450 mg every 2 weeks for 4 months) achieving no clinical response (no improvement in chronic lichenified eczema or reduction in symptomatic flares of the disease) [129]. The most commonly reported side effects of omalizumab are mild and include local reaction at the injection site and increased risk of infections and headache; anaphylaxis is rare, and there is no demonstrated carcinogenesis risk [115, 118, 119, 128]. Data on omalizumab efficacy in adult AD are controversial.…”

Atopic dermatitis phenotypes and the need for personalized medicine

“…Based on physicians’ assessment, 62.5% of the patients experienced a benefit of the treatment, overall 50% had a good or excellent response to the mAb. A limitation of this study was that the severity of atopic dermatitis was not assessed using a validated scoring system (SCORAD, IGA) [21]. In a literature search the authors identified 26 studies which report about the efficacy of treatment of atopic dermatitis with omalizumab in a total of 174 patients.…”

“…A beneficial effect was documented in 74.1% of all patients, with a degree of improvement from little to complete response. Omalizumab was safe and well tolerated [21]. However, the efficacy was not validated in phase III trials.…”

What's new in atopic eczema? An analysis of systematic reviews published in 2016. Part 1: treatment and prevention

“…Holm et al . analysed 2 small RCTs, 5 case studies and 19 case series (174 participants) in their SR.…”